ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

Phase 2

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Avacincaptad Pegol; Drug: Lucentis

• Registration Number: NCT03362190
• Lead Sponsor: Ophthotech Corporation

Brief Summary

To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Primary Completion: 2018-10-18
• Study Completion: 2018-10-18
• Disposition First Submitted: 2019-10-18
• Results First Submitted: 2021-10-14
• Results First Submitted QC: 2022-01-05
• Disposition First Submitted QC: 2022-01-05
• Results First Posted: 2022-02-02
• Disposition First Posted: 2022-02-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-25
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Active subfoveal NVAMD

Exclusion Criteria

• History or evidence of severe cardiac disease
• Any major surgical procedure within one month of trial entry
• Subjects with a clinically significant laboratory value
• Any treatment with an investigational agent in the past 60 days for any condition
• Women who are pregnant or nursing
• Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
• Any prior treatment for AMD other than oral supplements of vitamins and minerals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Avacincaptad Pegol	Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg
Cohort 1	Lucentis	Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg
Cohort 3	Avacincaptad Pegol	Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg
Cohort 2	Avacincaptad Pegol	Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg
Cohort 2	Lucentis	Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg
Cohort 3	Lucentis	Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg
Cohort 4	Lucentis	Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg
Cohort 4	Avacincaptad Pegol	Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg

Primary Outcome Measures

Name	Time	Method
Ophthalmic Adverse Events	6 months	Number of participants with ophthalmic Adverse Events (with calculated percentage)
Systemic Adverse Events	6 months	Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)

Trial Locations

Locations (28)

Retinal Research Institute; 🇺🇸 Phoenix, Arizona, United States

Retina Centers PC; 🇺🇸 Tucson, Arizona, United States

Retina Associates SW, PC; 🇺🇸 Tucson, Arizona, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Retina Consultants of Orange County; 🇺🇸 Fullerton, California, United States

Retina Consultants of Southern California; 🇺🇸 Redlands, California, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

Orange County Retina Medical Group; 🇺🇸 Santa Ana, California, United States

Colorado Retina Associates; 🇺🇸 Golden, Colorado, United States

Florida Eye Clinic; 🇺🇸 Altamonte Springs, Florida, United States

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